BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDLINE CATHETER UMBILICAL 4.0 FR

    MDR report key: 3677577 · Received January 15, 2014

    Report

    Report Number
    3677577
    Event Type
    Death
    Date Received
    January 15, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 14, 2014
    Manufacturer
    SPECIALTY MEDICAL
    Product Code
    FOS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFANT (B)(6)) BORN WEIGHING (B)(6) ON (B)(6) 2013. UMBILICAL VENOUS AND ARTERIAL CATHETERS PLACED AT BIRTH FOR TREATMENT. ON (B)(6) 2013 EVENING, INFANT WENT INTO SHOCK. UMBILICAL VENOUS CATHETER SUSPECTED TO HAVE PERFORATED LIVER. INFANT CONFIRMED TO HAVE HEMOPERITONEUM. CATH (VENOUS) REMOVED. INFANT HAD INCREASED OXYGEN NEEDS, COAGULOPATHY AND METABOLIC ACIDOSIS. INFANT EXPIRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38136 MEDLINE CATHETER UMBILICAL 4.0 FR UMBILICAL VENOUS CATHETER FOS SPECIALTY MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Death